The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease (0030-10)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Ziv Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01139632
First received: June 6, 2010
Last updated: April 5, 2011
Last verified: June 2010
  Purpose

The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.


Condition
Nonalcoholic Fatty Liver Disease
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Background: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of our study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2.

Methods: 60 patients with chest pain and low to intermediate risk for coronary events will undergo Cardiac CT and blood test measurement of enzyme PLA2, markers of inflammation: CRP, MDA(Malondialdehide), Paraoxonase, FFA(Free Fatty Acids), TG(Triglycerids) will performed.

CAD is defined as a stenosis of more than 50% in at least one major coronary artery, unstable plaque defined as low attenuated plaque <30HU and fatty liver defined as difference in liver and spleen attenuation value -10HU by using CT.

Expected results : we expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.
  2. Male and female 18years or older.

Intermediate Risk patients for having significant CAD is defined as:

a - chest pain or dyspnea in the presence of negative stress tests; b - the absence of chest pain but positive stress tests; c - the absence of chest pain and of positive stress tests but intermittent arrhythmias.

Age <18 years.

Criteria

Inclusion Criteria:

  1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.
  2. Male and female 18years or older.
  3. Able to provide written informed consent.

Intermediate Risk patients for having significant CAD is defined as:

  • chest pain or dyspnea in the presence of negative stress tests;
  • the absence of chest pain but positive stress tests;
  • the absence of chest pain and of positive stress tests but intermittent arrhythmias

Exclusion Criteria:

  1. Acute coronary syndrome presentation:

    • ST segment deviation on ECG and/or
  2. Cardiac troponin elevation.
  3. Chest pain in combination with positive tests for myocardial ischemia
  4. Hemodynamic instability on presentation.
  5. Inability to write inform consent.
  6. Age <18 years.
  7. Participation in an investigational study within the previous 30days.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01139632

Locations
Israel
Ziv medical center liver unit
Safed, Israel, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Nimer Assy, MD ZIV MEDICAL CENTER, SAFED ISRAEL
  More Information

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01139632     History of Changes
Other Study ID Numbers: 0030-10
Study First Received: June 6, 2010
Last Updated: April 5, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
NAFLD
lP-pla2
Coronary Arthery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Liver Diseases
Fatty Liver
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 01, 2014